Tele-health Enabled Clinical Trial for COVID-19

NCT04489628 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: STUDY20200461
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.

Conditions

SARS-CoV Infection

Keywords

Vitamin D; Telehealth; SARS-CoV-2; Immune Storm

Outcome Measures

Primary Outcomes (1)

• Patients requiring admission to the hospital or experiencing death

  Proportion of patients requiring admission to the hospital or experiencing death by Day 15

  Days 1 to 15

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.

Drug: Vitamin D3 or Placebo; Device: Doctella telehealth monitoring

Placebo

PLACEBO COMPARATOR

Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.

Device: Doctella telehealth monitoring

Interventions

Vitamin D3 or Placebo DRUG

): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.

Vitamin D

Doctella telehealth monitoring DEVICE

Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.

Placebo; Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Laboratory confirmed SARS-CoV-2 infection \< 4 days before randomization
• Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) \<4 days before admission
• Asymptomatic or mild symptoms (not requiring hospital admission)
• Access to and ability to use a mobile phone with telehealth capability

You may not qualify if:

• Unable to provide informed consent or comply with study directions
• Admitted to an acute care bed
• Baseline serum calcium \< 8.8 mg/dL or \> 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care)
• Women who are currently breastfeeding
• History of kidney stone in the past year or h/o multiple (\>1) previous kidney stones
• Does not have a smart phone that can download apps from Google Play or App Store.
• No way to keep the phone charged consistently
• The smartphone is shared with another individual.
• Required laboratory data is unavailable (eg calcium levels)
• No new oxygen requirement (see remote monitoring document)
• Pregnant and lactating mothers.
• Vitamin D level of 80ng/ml and above
• No lab work for calcium or vitamin D completed in ED

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kevin Cooper, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Wesley Yu, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 28, 2020
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)